A Follow-on Study for Second-Eye Treatment for Participants Previously Treated With Gene Therapy for X-Linked Retinitis Pigmentosa (XLRP)

Plain-language summary

This study evaluates second-eye treatment with the AAV5-hRKp.RPGR gene therapy in participants previously treated for X-linked retinitis pigmentosa, an inherited eye disease. People who were treated in the earlier MGT009 study and enrolled in Study MGT010 may take part. It is a Phase 2 study that is currently active but not recruiting new participants.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 2

Status

Active, not recruiting

Sponsor

Janssen Research & Development, LLC

Intervention

AAV5-hRKp.RPGR, No intervention (Follow-Up assessment)

Start date

10/10/2024

Estimated completion

10/24/2030

Countries

United States, United Kingdom

Related genes

Locations

• Boston, United States
• Ann Arbor, United States
• London, United Kingdom

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

* Have been treated with AAV5-hRKp.RPGR in study MGT009 and have completed or is currently enrolled in Study MGT010
* Must sign an informed consent form indicating that they understand the purpose and procedures of the study and is willing to participate in the study
* Willing to adhere to the protocol and long-term follow-up

Exclusion Criteria:

\- There are no specific exclusion criteria to enroll in this study